BARCELONA — Valve replacement is the new frontier for minimally invasive coronary interventions, and three companies have emerged as front-runners in the race to stake out a claim of a market that senior executives from each company described, in a word, as “huge.”
CoreValve (Irvine, California) won the pole position, in mid-May reporting receipt of a CE mark for its transfemoral percutaneous aortic valve replacement device.
Rob Michiels, COO of CoreValve, told Cardiovascular Device Update at the recent EuroPCR meeting — Europe’s largest interventional cardiology event — that the company would soon file for an Investigational Device Exemption from the FDA and expects to start a pivotal trial for pre-market approval before the end of this year.
Founded in 2001 by noted French interventional cardiologist Jacques Séguin, MD, who serves as CEO and chairman, privately held CoreValve raised $33 million in March to underwrite product and market development.
Edwards Lifesciences (Irvine, California) is the heavyweight in the field, with a 30-year track record and enrollment under way since March for a pivotal trial totaling some 600 patients. Edwards expects to receive CE-marking for its transfemoral device by year-end.
The dark horse in the race is JenaValve (Munich, Germany), which just weeks ahead of the EuroPCR gathering, reported that it had secured EUR 3.5 million ($4.8 million) and put its management team in place. Offices were moved from Germany’s innovation hotbed in Jena to a corporate center in Munich.
JenaValve brings to market a unique anchoring stent for valve placement compared to what it termed the “passive” anchors of its competitors that it said risk “mispositioning.”
CEO Helmut Straubinger told CDU, “This is a very high-potential market with only a few competitors and a lot of ideas. We expect a $2 billion market share among industrial countries, where the total [global] market today is $2.1 billion.”
A sign of the growing interest among interventional cardiologists in this emerging practice area could be seen at the EuroPCR meeting, where valve and non-coronary cardiac disease was one of four dedicated tracks offering four days of courses, lectures and live demonstrations. This year’s EuroPCR gathering also incorporated the Transcatheter Valve Symposium, which until this event, had only been held in the U.S.
“Heart valves is a dynamic research and development area, as a total of 35 companies are currently working in this area,” said Philipp Bonhoeffer, professor and chief of cardiology at the Great Ormond Street Hospital for Children (London) and chairman for several percutaneous valve plenary sessions at EuroPCR.
“Here is where the frontier lies,” said CoreValve’s Michiels, quickly sketching a pie chart divided into three wedges. “The market is going to split into three approaches for intervention — open-heart surgery, transfemoral catheter and transapical catheter. The challenge is to know what will be the size of each of these pieces of the pie.”
He added, “Everyone needs to answer that question, and we already know where we want to go,” noting that the funding received in March accelerated CoreValve’s development of a transapical transcatherter device.
Heart attack outcomes better if patient taken to specialists
Research presented at last month’s annual conference of the British Cardiovascular Society (London) shows that many heart attack patients are more likely to survive if paramedics take them directly to specialist heart attack centers for emergency primary angioplasty, rather than local accident and emergency departments for traditional clot-busting treatment.
Dr. Miles Dalby, a consultant cardiologist at Harefield Hospital, and colleagues compared the outcome of 180 patients who received direct primary angioplasty at Harefield in Middlesex to the outcome of 181 patients who received the thrombolysis treatment at district general hospitals in the preceding two years. The results showed that direct primary angioplasty with rapid arrival-to-treatment times had a “significantly higher” survival rate than thrombolysis.
Dalby said patients who were taken directly to Harefield by paramedics for primary angioplasty had a very low 30-day mortality rate of less than 3%. “This shows a very large and significant mortality benefit when compared to patients who received thrombolysis treatment,” he said. That patient group had a mortality rate of 9%.
The research highlights the need for rapid treatment, showing that while a less than 3%, 30-day mortality rate for primary angioplasty was achieved when patients were taken directly to Harefield by ambulance, those who went to district general hospitals first and later were transferred to Harefield for primary angioplasty had a much higher mortality rate.
Dalby said that prompt treatment is the essence of an effective primary angioplasty service and requires an exceptionally high level of commitment from the whole team: “During a heart attack, blood flow to the heart muscle is blocked, which damages it,” he said. “The sooner the patient receives treatment enabling the blood flow to return to the coronary arteries, the less damage occurs. This gives better long-term results — time is muscle.”
Danish stent study boosts use of Cordis’ Cypher over Taxus
An analysis of data from the Western Denmark Heart Registry has found that patients who received a Cypher sirolimus-eluting coronary stent to open a clogged artery were less likely to need another procedure at that same lesion site — called target lesion revascularization (TLR) — than were patients who received a Taxus stent. The analysis was published in the June 1 issue of the journal Heart.
The authors sought to identify risk factors for symptom-driven TLR when patients were treated with the Cypher from Cordis (Miami Lakes, Florida) or the Taxus stent from Boston Scientific (Natick, Massachusetts) in a real-world scenario. From Jan. 1, 2003, to May 18, 2005, 4,432 patients in Western Denmark were treated with a drug-eluting stent, with 2,728 receiving Cypher stents and 1,704 getting Taxus stents.
Researchers said use of a Taxus stent, implantation of multiple stents per lesion and stent implantation in small vessels were found to be independent predictors of the need for TLR at nine months after the procedure.
“The major new finding of this study was that the use of the Taxus stent was an independent predictor of TLR for a real-world population of patients treated with the Cypher stent and the Taxus stent,” said Michael Maeng, MD, principal investigator from Denmark’s Aarhus University Hospital.
The Cypher yielded a 20% relative reduction of TLR in large vessels (2.4% vs. 3% in arteries with a reference diameter equal to or greater than 2.8 mm) and a 40% relative reduction of TLR in small vessels (2.9% vs. 4.8% in vessels less than 2.8 mm in diameter) compared to the Taxus.
“These registry findings provide additional assurance to the interventional cardiology community regarding the efficacy of the Cypher stent to prevent the need for repeat revascularizations in a real-world clinical setting,” said David Kandzari, MD, chief medical officer of the Cordis Cardiology Division.
The Cypher stent is available in more than 80 countries. The next version of Cordis’ sirolimus-eluting stent, the Cypher Select, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The Cypher Select Plus, the third version of the company’s sirolimus-eluting DES received the CE mark last year and is available in many markets outside the U.S.
St. Jude receives CE mark for ‘first-of-its-kind’ pacing lead
St. Jude Medical (St. Paul, Minnesota) reported receiving the CE mark for its new OptiSense lead, which the company calls “a first-of-its-kind pacing lead designed to offer more accurate sensing in the upper chamber of the heart.” The lead, introduced at the Europace 2007 meeting in Lisbon, Portugal, incorporates a new tip design that St. Jude said increases the device’s ability to detect and classify electrical signals in the atrium more accurately by avoiding picking up signals from the heart’s lower chambers. According to the company, this improves the pacemaker’s response to sensed signals and the accuracy of device diagnostic reports.
St. Jude said the improved device therapy has now been demonstrated in two completed clinical trials. Results from the International OptiSense Lead Clinical Study were presented at the Europace meeting by Johannes Sperzel, MD, of the Kerckhoff-Klinik (Bad Nauheim, Germany).
The company said that because the design of the OptiSense lead “allows for more accurate detection of impulses from the patient’s atrium,” the lead offers physicians greater flexibility in programming the device’s atrial sensitivity settings while avoiding the sensing of signals from the ventricles.
In the past, physicians sometimes had to program a pacemaker to be less sensitive in order to avoid the detection of interfering signals. While decreasing the sensitivity settings helps to reduce the interfering signals, St. Jude noted. It also can reduce the sensing of important signals, “such as the small signals that can occur during atrial arrhythmias.”
In reducing the detection of unwanted signals, the OptiSense lead also provides greater freedom in lead placement options. Physicians may be able to place leads lower in the atrium — a potentially optimal location for pacing that previously created challenges because of interfering signals from the heart’s lower chambers. St. Jude said the improved sensing performance of the OptiSense is the result of compressed spacing between the lead’s tip and ring. The 1.1 mm tip-to-ring spacing reduces oversensing of far-field R-wave signals.
In addition to the OptiSense lead, St. Jude also debuted its newest pacemakers — the Zephyr family of devices — at Europace 2007. The Zephyr pacemaker is designed to save clinic time by automatically performing all standard follow-up testing before the patient arrives in the clinic. The stored diagnostics, trends and measurements from the automatic tests are displayed for evaluation. The company said the Zephyr device also is the first pacemaker that can, in about 90 seconds, tell physicians which device timing settings are optimal for each patient’s needs, via the QuickOpt Timing Cycle Optimization feature.
Canadian device license for BioSTAR
NMT Medical (Boston) reported receiving a medical device license in Canada for its BioSTAR bioabsorbable septal repair implant technology and Rapid Transport delivery system. The approval was required in order to begin commercialization in Canada. BioStar incorporates a purified acellular collagen matrix delivered on the company’s StarFlex alloy framework and uses NMT’s latest Rapid Transport delivery system. The BioStar implant will be offered in three sizes: 23 mm, 28 mm and 32 mm.
BioStar is designed to provide biological closure of atrial level defects using the patient’s natural healing response. Between 90% and 95% of the implant is absorbed over time and replaced with healthy native tissue.
Data from the prospective multi-center BEST (BioSTAR Evaluation STudy) trial, published in the October 2006 edition of the journal Circulation, demonstrated that BioSTAR provides a more rapid and complete closure of atrial septal defects, with a 92% closure rate at 30 days and 96% at six months, NMT said.
NMT previously reported receiving conditional approval from the FDA for inclusion of BioStar in the MIST II PFO/migraine headache trial currently under way in the U.S.
Sorin in accord with JLL for CRM distribution in Japan
The Sorin Group (Milan, Italy) and Japan Lifeline (JLL; Tokyo), a distributor of medical devices, have signed a 10-year partnership agreement whereby JLL will distribute Sorin’s cardiac rhythm management (CRM) devices throughout Japan. Sorin said it expects that the agreement will “significantly” boost its market share in that country.
More than 200 field representatives, coming both from JLL and Sorin’s Japanese subsidiary, will distribute Sorin’s CRM devices. The sales force, which will be employed by JLL, “will secure greater penetration in this growing, sophisticated medical technologies market,” Sorin said. In 2006, Japan had more than 50,000 pacemaker and more than 3,500 defibrillator implants, for more than E360 million in value.
JLL already distributes Sorin’s Carbomedics-brand heart valves in Japan. The new partnership agreement takes effect Sept. 1.
Sorin said the partnership comes at a time when the company has just received approval for its family of Ovatio ICD devices in Japan, which it called “the world’s smallest” ICD.
Kensey Nash completes safety study of ThromCat in the EU
Kensey Nash (Exton, Pennsylvania) reported completing a European Union study to assess the safety and performance of the company’s ThromCat Thrombectomy Catheter System during percutaneous coronary intervention (PCI). The trial enrolled more than 60 patients at seven sites in Germany, and was designed to study outcomes of patients in both acute and elective PCI settings who had thrombus present in their native coronary arteries, the company said.
The ThromCat System is a mechanical thrombectomy catheter designed to remove blood clots in patients. In Europe, it is indicated for use in coronary and certain peripheral arteries.
Hospital discharge results, presented by the company at the EuroPCR meeting in Barcelona, demonstrated more than 90% device success, patient safety and desired device performance, with 70% thrombus removal by volume. Kensey Nash said the study results “also showed strong improvements to TIMI flow measurements and myocardial blush scores, with only 1.6% of the patients needing temporary pacing.”
More than half of the patients enrolled had presented with an acute myocardial infarction.
The ThromCat system is a fully disposable catheter system that incorporates Kensey Nash’s HeliFlex technology to flush, macerate and extract thrombus. An internal rotating helix creates a powerful vacuum to draw thrombus into the catheter and then macerate it, while simultaneously flushing the vessel to aid in the thrombus removal.